Cleared Traditional

icotec Anterior Cervical Plate System

K233215 · Icotec AG · Orthopedic
May 2024
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K233215 is an FDA 510(k) clearance for the icotec Anterior Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Icotec AG (9450 Altstaetten (Sg), CH). The FDA issued a Cleared decision on May 17, 2024, 234 days after receiving the submission on September 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K233215 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2023
Decision Date May 17, 2024
Days to Decision 234 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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